Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC Trial)

Exclusion Criteria

• •Received an investigational agent within 4 weeks prior to screening;
• •Stage T4 prostate cancer by clinical examination or radiologic evaluation;
• •Hypogonadism or severe androgen deficiency as defined by screening serum testosterone below the normal range for the institution;
• •Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer;
• •Receiving concurrent androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to randomization;
• •History of another malignancy within the previous 5 years other than curatively treated nonmelanomatous skin cancer and non-muscle invasive bladder cancer;
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiovascular disease, unstable angina pectoris, cardiac arrhythmia that is symptomatic or requires active therapy; deep venous thrombosis within 3 months prior to randomization;
• •Previous use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., enzalutamide, BMS 641988);
• •Liver injury or disease (e.g., viral hepatitis, liver failure Child-Pugh Class C).